Xgeva. Xgeva (denosumab) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Xgeva Page: 1 of 5 Last Review Date: March 16, 2018 Xgeva Description Xgeva (denosumab) Background Xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors and for treatment of giant cell tumor of bone. Xgeva binds to the protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Increased osteoclast activity is a mediator of solid tumor bone metastases. Similarly, giant cell tumors of bone and osteoclast-like giant cells contribute to osteolysis and [bone] tumor growth. Xgeva prevents activation of osteoclasts, their precursors, and osteoclast-like giant cells (1). Regulatory Status FDA-approved indications: Xgeva is a RANK ligand (RANKL) inhibitor indicated for: (1) Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity Hypercalcemia of malignancy refractory to bisphosphonate therapy Xgeva is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Xgeva (1).

2 Subject: Xgeva Page: 2 of 5 Xgeva may increase risks for osteonecrosis of the jaw, hypocalcemia, and atypical femoral fracture (1). Related policies Prolia Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Xgeva may be considered medically necessary in patients 13 years and older for the treatment of giant cell tumor of bone whose tumor is unresectable or for whom surgical resection is not recommended; and if the conditions below are met. Xgeva may also be considered medically necessary in patients 18 years of age and older who have bone metastases from solid tumors, multiple myeloma or hypercalcemia due to malignancy; and if the conditions below are met. Xgeva may be considered investigational for all other patients and for all other indications. Prior-Approval Requirements 13 years of age or older Diagnosis Patient must have the following: 1. Giant cell tumor of bone a. Tumor is unresectable or surgical resection is not recommended b. Pre-existing hypocalcemia must be corrected prior to initiating therapy c. NO concurrent use with another RANKL-inhibitor 18 years of age or older Diagnoses Patient must have ONE of the following:

3 Subject: Xgeva Page: 3 of 5 1. Bone metastases from solid tumors 2. Multiple myeloma AND ALL of the following for BOTH indications: a. At high risk for skeletal-related events b. Pre-existing hypocalcemia must be corrected prior to initiating therapy c. Inadequate treatment response, intolerance, or contraindication to ONE of the following: i. IV Bisphosphonate ii. Pamidronate iii. Zoledronic acid 3. Hypercalcemia of malignancy a. Disease must have relapsed or progressed after bisphosphonate therapy AND the following for ALL indications: Prior Approval Renewal Requirements 13 years of age or older Diagnosis Patient must have the following: 1. Giant cell tumor of bone 18 years of age or older Diagnoses Patient must have ONE of the following:

4 Subject: Xgeva Page: 4 of 5 Policy Guidelines Pre - PA Allowance None 1. Bone metastases from solid tumors 2. Multiple myeloma 3. Hypercalcemia of malignancy AND the following for ALL indications: Prior Approval Limits Quantity Duration 5 vials per 84 days 3 months Prior Approval Renewal Limits Quantity Duration 3 vials per 84 days 12 months Rationale Summary Xgeva an osteoclast inhibitor is used to treat complications of bone metastases in patients with multiple myeloma and in patients with solid tumor cancers, for treatment of giant cell tumor of bone and for hypercalcemia of malignancy refractory to bisphosphonate therapy. Xgeva may increase risks for osteonecrosis of the jaw, hypocalcemia, and atypical femoral fracture. The safety and efficacy of Xgeva have not been established in pediatric patients except in skeletally mature adolescents with giant cell tumor of bone (1). Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Xgeva while maintaining optimal therapeutic outcomes. References 1. Xgeva [package insert]. Thousand Oaks, CA: Amgen Inc.; January 2018.

5 Subject: Xgeva Page: 5 of 5 Policy History Date March 2015 June 2015 December 2015 March 2016 September 2016 December 2017 January 2018 March 2018 Action Addition to PA Added new indication hypercalcemia of malignancy Addition to the bone metastases of inadequate treatment response, intolerance, or contraindication to one of the following: IV bisphosphonate, pamidronate, or zoledronic acid and addition of quantity limits and change to initial PA duration to 3 months per PMPC Policy number changed from to Addition of age requirement to renewal section Addition of multiple myeloma indication Removal of the requirement of no concurrent diagnosis of multiple myeloma Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on March 16, 2018 and is effective on April 1, 2018.